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The New York Times reveals the frequent and controversial practice of prescribing multiple psychiatric drugs for young people in the USA, a practice sometimes known as "chemical cocktails" or "polypharmacy."

Proof is Scant on Psychiatric Drug Mix for Young

Date Published:

Nov 23, 2006 03:00 AM

Author:
Gardiner Harris

Source:
The NY Times

Their rooms are a mess, their trophies line the walls, and both have profiles on MySpace.com. Stephen and Jacob Meszaros seem like typical teenagers until their mother offers a glimpse into the family’s medicine cabinet.

Bottles of psychiatric medications fill the shelves. Stephen, 15, takes the antidepressants Zoloft and Desyrel for depression,
the anticonvulsant Lamictal to moderate his moods and the stimulant
Focalin XR to improve concentration. Jacob, 14, takes Focalin XR for
concentration, the anticonvulsant Depakote to moderate his moods, the
antipsychotic Risperdal to reduce anger and the antihypertensive
Catapres to induce sleep.

Over the last three years, each boy has been prescribed 28 different psychiatric drugs.

“Sometimes, when you look at all the drugs they’ve taken, you
wonder, ‘Wow, did I really do this to my kids?’ ” said their mother,
Tricia Kehoe of Sharpsville, Pa. “But I’ve seen them without the meds,
and there’s a major difference.”

There is little doubt that some psychiatric medicines, taken by
themselves, work well in children. For example, dozens of studies have
shown that stimulants improve attentiveness. A handful of other
psychiatric drugs have proven effective against childhood obsessive
compulsive disorder, among other problems.

But a growing number of children and teenagers in the United States
are taking not just a single drug for discrete psychiatric difficulties
but combinations of powerful and even life-threatening medications to
treat a dizzying array of problems.

Last year in the United States, about 1.6 million children and
teenagers — 280,000 of them under age 10 — were given at least two
psychiatric drugs in combination, according to an analysis performed by
Medco Health Solutions at the request of The New York Times. More than
500,000 were prescribed at least three psychiatric drugs. More than
160,000 got at least four medications together, the analysis found.

Many psychiatrists and parents believe that such drug combinations,
often referred to as drug cocktails, help. But there is virtually no
scientific evidence to justify this multiplication of pills,
researchers say. A few studies have shown that a combination of two
drugs can be helpful in adult patients, but the evidence in children is
scant. And there is no evidence at all — “zero,” “zip,” “nil,” experts
said — that combining three or more drugs is appropriate or even
effective in children or adults.

“There are not any good scientific data to support the widespread
use of these medicines in children, particularly in young children
where the scientific data are even more scarce,” said Dr. Thomas R.
Insel, director of the National Institute of Mental Health.

Psychiatrists who prescribe drug combinations say that the ability
to mix and match medications improves their chances of being able to
help children who are seriously, even desperately, ill.

Dr. Joseph Biederman, a professor of psychiatry at Harvard, said that doctors commonly used multiple medicines to treat heart disease, diabetes, cancer and AIDS.
“Child psychiatry is not any different,” Dr. Biederman said. “These
drugs have revolutionized how we treat severe psychopathology in
children.”

The controversy leaves parents in a terrible bind. Desperate to help, many agonize over whether to medicate their children.

Mothers and fathers sometimes disagree, with the dispute straining
or even ending marriages. Since some psychiatric drugs can cause
worrisome physical effects, parents say that they must on occasion make
a terrifying choice between their child’s physical health and his mental health.

The parents interviewed for this article told their stories, they
said, in hopes of gaining greater acceptance for their children and
themselves. Nearly all recalled being in a store when their child threw
a tantrum and feeling that onlookers branded them as bad parents. They
also said they hoped to help others negotiate what many said were
unequal and often fraught relationships with psychiatrists.

“We struggled so much, made so many mistakes and felt so
stigmatized, I hope our story can make it easier for others,” said
Jacquie Erickson of Anchorage. Her daughter, Kaitlyn Johnston, 10, has
taken psychiatric drugs since she turned 5 for diagnoses that include bipolar disorder.

On Shaky Ground

Stimulants like Ritalin are by far the most commonly prescribed
psychiatric medicines in children. But doctors routinely pair
stimulants with antidepressants, antipsychotics and anticonvulsants,
even though some of these medications can cause serious side effects,
have few proven pediatric psychiatric benefits and lack clear evidence
about how they interact or influence mental and physical development.

Last year, the Food and Drug Administration
required drug makers to warn on their labels that antidepressants can
cause suicidal thoughts and behavior in some children. Anticonvulsant
drugs carry warnings about liver and pancreas damage and fatal skin
rashes. The side effects of antipsychotic medicines can include rapid
weight gain, diabetes, irreversible tics and, in elderly patients with
dementia, sudden death. When drugs are combined, these risks compound.

Ms. Kehoe, who receives government financial and child-care
assistance because her children are considered mentally ill, said she
knew that there were risks to the drug cocktails. Both her sons are
short and underweight for their age — a common side effect of
stimulants — and she fears that the drugs have affected their health
and behavior in other ways.

“But I don’t think the insurance would pay for it if the F.D.A.
didn’t decide that children should use it,” said Ms. Kehoe, who herself
takes psychiatric medication.

In fact, the drug agency has specifically warned against the use of
Lamictal, one of the drugs Stephen takes, in children who, like him, do
not suffer from seizures because in 8 out of 1,000 children the drug
causes life-threatening rashes.

Stephen and Jacob’s psychiatrist did not reply to telephone messages
left with an office secretary on three different days. Ms. Kehoe said
that she asked him to speak to this reporter but that he refused. The
boys have had 11 psychiatrists over the last three years, according to
prescription records, and many more before that, Ms. Kehoe said.

In interviews, Stephen and Jacob said they hated taking their drug cocktails.

“I see the hyperness in him,” she said. “My pediatrician has said that he would venture to say that Lucas will be A.D.H.D.”

Stephen and Jacob were Lucas’s age — 6 — when they were given their first prescriptions.

The F.D.A. requires drug makers to prove that their drugs work
safely before the agency will approve them for sale in the United
States. But doctors can prescribe and combine approved medicines as
they see fit. Such mixing is common in medicine but rarely studied by
drug makers.

Psychiatrists started mixing psychiatric medications because the
drugs were only moderately effective and often caused terrible side
effects, said Dr. Steven E. Hyman, the provost of Harvard University
and former director of the National Institute of Mental Health. “None
of these drugs by themselves do an adequate job of controlling
symptoms,” Dr. Hyman said.

If one drug failed, many psychiatrists assumed that two or more
drugs used together might succeed. For decades, no one studied whether
this was accurate. But in recent years, a trickle of studies have
examined the question, with mixed results.

In studies in adults, some combinations of two drugs have been shown
to work better than single medications to improve the symptoms of
depression, obsessive-compulsive disorder
and the mania associated with bipolar disorder. For example, a recent
large government-financed study in adults, published in The New England Journal of Medicine,
found that two antidepressants worked a bit better than one for adults
who suffered from chronic, severe depression. But other studies have
found no benefit from commonly prescribed drug combinations.

The use of two-medicine combinations in children is on much shakier
ground. Even for single drugs, the effectiveness of some psychiatric
medications in younger patients is questionable: most trials of
antidepressants in depressed children, for instance, fail to show any
beneficial effect. But hardly any studies have examined the safety or
the effectiveness of medicine combinations in children. A 2003 review
in The American Journal of Psychiatry found only six controlled trials
of two-drug combinations. Four of the six failed to show any benefit;
in a fifth, the improvement was offset by greater side effects.

“No one has been able to show that the benefits of these
combinations outweigh the risks in children,” said Dr. Daniel J. Safer,
an associate professor of psychiatry at Johns Hopkins University and an author of the 2003 review.

If the evidence for two-drug combinations is minimal, for three-drug combinations it is nonexistent, several top experts said.

“The data is zip,” Dr. Hyman said.

Many psychiatrists said that they turned to drug cocktails only in
desperate circumstances. “If you’ve got a 15-year-old who is cutting up
her arms, you’ve got a barn on fire and what are you supposed to do?”
asked Dr. Alexander Lerman, a child and adolescent psychiatrist in New
York, who said he rarely prescribed combinations.

Billy and Jackie Igafo-Te’o of Jackson, Mich., are among the
desperate. In the last seven years, their 12-year-old son, Michael,
“has been on just about everything you can put a child on,” Mrs.
Igafo-Te’o said. He is now taking four medications: an antipsychotic,
an anticonvulsant, an antidepressant and a sleep medicine.

Despite the medications, Michael’s behavior has grown increasingly
disruptive. He has kicked and punched holes in almost every wall of the
Igafo-Te’o home. He wrenched the sink off the wall in the upstairs
bathroom and pulled two bedroom doors off their hinges, damaging the
frames. The family no longer fixes the damage.

During a recent visit, Michael and Mr. Igafo-Te’o were sitting on
the living-room floor. Michael wanted the phone. His father held it out
of reach to prevent Michael from playing with it. Michael became
increasingly desperate. He cried. He cursed.

“That’s it, you have a timeout,” Mr. Igafo-Te’o said.

“No, no, no,” Michael answered. “You pimp!”

He slapped his father in the face, hard. Mr. Igafo-Te’o hustled Michael into the kitchen and forced him to sit for 20 minutes.

“What’s the purpose of all this medication if I still have to do that?” Mr. Igafo-Te’o asked.

He said he wanted to end Michael’s drug therapy. Among other side effects, the drugs have made Michael obese, which has led to asthma.

Mrs. Igafo-Te’o quietly disagreed. “I’m afraid he wouldn’t be able to focus,” she said. “I’m afraid he would regress socially.”

“Regress socially? Look at him!” her husband responded, motioning to their son, crying uncontrollably on the kitchen floor.

“I have to believe in something,” his wife mumbled and walked out of the room.

Mr. Igafo-Te’o watched her go and then smiled apologetically.

“We always debate meds,” he said.

Divergent Views

Most experts agree that some children are so violent or suicidal
that a combination of psychiatric drugs is worth trying. But recently,
more psychiatrists have been asking whether in some cases drugs are
being prescribed for children who do not need them, or for problems
that fall within the spectrum of normal behavior. The doubters are
especially concerned with the growing use of drug combinations for
preschoolers.

Fate Riske, 3, of Fond du Lac, Wis., takes two antipsychotics and a
sleeping medicine to control what her mother, Elizabeth Klein-Riske,
said were hours-long tantrums, a desire to watch the same movies
repeatedly and an insistence on eating the meat, cheese and bread in
her sandwiches separately.

On a recent visit, Fate played sweetly for four hours as her
parents, who both have trouble walking, sat in front of a television.
Sucking on a pacifier, Fate showed off her pink dress and matching
shoes.

Mrs. Klein-Riske credited the drugs for Fate’s cherubic behavior
during the visit. But a few weeks on a different antipsychotic led Fate
to become aggressive, talk rapidly and “run around wild, totally out of
control,” said Mrs. Klein-Riske, who receives government financial and
child-care assistance because her daughter is considered mentally ill.

Fate’s weight ballooned in five months to 48 pounds from 30.

Dr. Gary Sachs, director of the Bipolar Clinic and Research Program at Massachusetts General Hospital
in Boston, estimated that half the children referred to his clinic for
research in recent years — including many who took drug combinations —
had the wrong diagnosis and often did well on fewer drugs. “Even among
properly diagnosed bipolar patients, many come to our program already
taking medicines that interfered with each other,” Dr. Sachs said.

But Dr. Judith Rapoport, a senior investigator in child psychiatry
at the National Institute of Mental Health, said that in her
experience, few children were overmedicated. Dr. Rapoport studies
children with schizophrenia. Before entering her study, children must be drug-free for three weeks.

“We’ve had a handful of cases who are completely normal when they
get off drugs,” Dr. Rapoport said. “But most of these kids become very,
very sick and unmanageable without drugs.”

The first psychiatric problem diagnosed in most children is
attention deficit disorder, treated with stimulants — drugs that
improve attentiveness. But when children’s problems persist, parents’
relatively good experience with stimulants often convinces them to
agree to try other medicines — in some cases drugs like the
antipsychotic Risperdal or the anticonvulsant Depakote that have few
proven benefits in children and greater dangers, said Dr. Ranga
Krishnan, chairman of the department of psychiatry and behavioral
science at Duke University.

“After you get them on one drug, parents don’t seem to mind the
second,” said Dr. Krishnan, who said that he had grave doubts about the
growing use of psychiatric drug cocktails in children.

Antidepressants are commonly paired with stimulants, but
antidepressant use has declined over the last year after the F.D.A.
warning about suicide
risk. In their place, physicians are prescribing combinations that
include antipsychotic and anticonvulsant drugs, according to Medco.
From 2001 to 2005, the use of antipsychotic drugs in children and
teenagers grew 73 percent, Medco found. Among girls, antipsychotic use
more than doubled.

On Again, Off Again

Andrew Darr of Caldwell, Idaho, whose sons took medications, said
that he was opposed to it from the start. “When you come home from work
and instead of getting them clawing at your feet and yelling, ‘Daddy,
Daddy,’ you get a lethargic grunt, it just kills you,” Mr. Darr said.

His wife, Leslie Darr, eventually agreed to stop the medicines, but only after a family tragedy.

The Darrs have four children, Nicholas, 16, Nathan, 15, Becky, 12,
and Benjamin, 9. At 3, Nicholas suffered a mild brain injury when
undiagnosed appendicitis led him to suffer weeks of high fever, Mrs. Darr said.

Mrs. Darr said that she was pressured by school officials to give Nicholas a stimulant at age 6. Nathan soon followed.

Three years later, the boys had a traumatic weekend away with
relatives. A month after that, Mrs. Darr said, both were hospitalized
for a week and given a diagnosis of bipolar disorder and prescriptions
for antipsychotic, antidepressant and sleeping medicines.

Over the next three years, Nicholas’s weight ballooned to 140 pounds
from 52. Nathan went to 115 pounds from 48. Neither boy got much
taller, Mrs. Darr said. They did poorly in school.

Then Becky developed a brain tumor.
A nurse practitioner gave Mrs. Darr free samples of an antipsychotic
drug to help her cope. After starting it, she said, she could not sleep
or think straight. She realized that she had been giving similar
medicines to her sons for years and she decided to wean the boys off
the pills.

Their behavior immediately worsened. At one point, Nicholas left the
house during a blizzard wearing only boxer shorts, Mrs. Darr said. They
found him in a tire swing saying, “Baaa.”

“There were several times that we almost gave up,” Mr. Darr said.

But after four months off medication, the boys’ behavior normalized,
the Darrs said, and they were transferred out of special education and
into regular classes. The Darrs recently allowed the boys to spend
their first evening at a mall without supervision, and in July they
gave both boys their first bicycles. “They’ve come a long way,” Mrs.
Darr said.

In an interview, Nicholas said the drugs “were not cool.”

“You go to school and everybody thinks, ‘Look at that retard,’ ” he said.

Still, most of the parents interviewed for this article said their children’s behavior deteriorated rapidly without medication.

Joanne Johnson of Hillsborough, N.J., described a psychiatrist’s
effort to wean her 17-year-old son, Brad, off of all five of his
psychiatric medicines as “the biggest mistake of our lives.”

Brad, then 13, became suicidal and was hospitalized for weeks, Ms. Johnson said.

“He went into the hospital on five drugs and came out on five
different ones, but he was unstable,” she said. “It took a little over
two years to find the right match again.”

Brad is now taking lithium, an antipsychotic, an anticonvulsant, an antidepressant, a stimulant and a sleeping pill.

“He’ll probably be on these for the rest of his life,” Ms. Johnson said.

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